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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, ophthalmic
510(k) Number K010305
Device Name WEISS RETINAL CANNULA
Applicant
MICRON SURGICAL, INC.
5800 COLONIAL DR.
SUITE 300
MARGATE,  FL  33063
Applicant Contact APRIL DEAN
Correspondent
MICRON SURGICAL, INC.
5800 COLONIAL DR.
SUITE 300
MARGATE,  FL  33063
Correspondent Contact APRIL DEAN
Regulation Number886.4350
Classification Product Code
HMX  
Date Received02/01/2001
Decision Date 05/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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